United States Patent 8,906,938: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,906,938, titled "C5aR antagonists," is a significant patent in the pharmaceutical sector, particularly in the field of immunology and inflammatory diseases. This patent, assigned to ChemoCentryx, Inc., involves compounds that modulate the C5a receptor, a key component in the complement system.
Background and Context
The C5a receptor (C5aR) plays a crucial role in the immune response, particularly in the pathogenesis of various inflammatory and autoimmune diseases. The activation of C5aR by its ligand, C5a, can lead to the recruitment of inflammatory cells and the release of pro-inflammatory mediators, exacerbating conditions such as rheumatoid arthritis, kidney diseases, and other inflammatory disorders[4].
Patent Overview
Inventors and Assignee
The patent was invented by a team of researchers including Pingchen Fan, Kevin Lloyd Greenman, Manmohan Reddy Leleti, Yandong Li, Jay Powers, Hiroko Tanaka, Ju Yang, and Yibin Zeng, and is assigned to ChemoCentryx, Inc., a biopharmaceutical company based in Mountain View, California[2][4].
Issue Date and Expiration
The patent was issued on December 9, 2014, and is set to expire on December 21, 2029[2].
Claims and Scope
Compound Description
The patent describes a series of substituted piperidine compounds that act as antagonists of the C5a receptor. These compounds are designed to inhibit the activation of C5aR, thereby reducing the inflammatory response associated with various diseases[4].
Pharmaceutical Compositions
The patent includes claims for pharmaceutical compositions containing these C5aR antagonists, which can be formulated for various routes of administration, such as oral, intravenous, or topical. These compositions are intended for the treatment of diseases and disorders involving the pathologic activation of C5a receptors[4].
Therapeutic Applications
The compounds and pharmaceutical compositions claimed in this patent are useful in treating a range of diseases, including rheumatoid arthritis, kidney diseases such as ANCA-associated vasculitis, and other inflammatory conditions. The patent highlights the potential of these compounds in reducing the severity of these diseases by inhibiting the C5a/C5aR pathway[4].
Patent Landscape
Related Patents
This patent is part of a broader portfolio of patents related to C5aR antagonists held by ChemoCentryx, Inc. Other notable patents include US Patent 8,445,515, which also deals with C5aR antagonists and is set to expire on February 3, 2031[2].
Patent Term Restoration
The FDA has determined the regulatory review period for Tavneos, a drug related to this patent, which could lead to patent term restoration. The USPTO has received applications for patent term restoration for U.S. Patent Nos. 8,445,515 and 8,906,938, which could extend the patent term based on the regulatory review period[5].
Regulatory and Legal Aspects
Regulatory Review Period
The FDA has verified the regulatory review period for Tavneos, which includes 2,642 days from the date the investigational new drug application became effective to the date of approval. This period is crucial for determining any potential patent term extension[5].
Patent Term Extension
The applicant has sought patent term extensions of 1,476 or 1,549 days, which are subject to statutory limitations and FDA determinations regarding due diligence during the regulatory review period[5].
Impact on Innovation and Industry
Innovation Incentives
The issuance of this patent and others like it can influence innovation in the pharmaceutical industry. While broad patents can sometimes be criticized for impeding innovation due to licensing and litigation costs, narrower and clearer claims, as seen in this patent, can provide a more balanced approach that encourages further research and development[3].
Market and Competition
The absence of generic versions of Tavneos, a drug related to this patent, as of the current date, indicates that the patent remains a significant barrier to entry for competitors. This exclusivity period allows ChemoCentryx, Inc. to maintain market dominance for the patented compounds and formulations[2].
Clinical Relevance
Disease Models
Studies using animal models, such as collagen-induced arthritis in mice and rats, have shown that C5a levels correlate with the severity of the disease state. The compounds described in this patent have demonstrated potential in reducing the severity of such diseases by inhibiting the C5a/C5aR pathway[4].
Clinical Applications
The therapeutic potential of these C5aR antagonists extends to various clinical applications, including the treatment of autoimmune and inflammatory diseases. The specificity and efficacy of these compounds make them promising candidates for addressing unmet medical needs in these areas.
Key Takeaways
- Compound and Composition: The patent describes substituted piperidine compounds as C5aR antagonists and their pharmaceutical compositions.
- Therapeutic Use: These compounds are useful in treating diseases involving the pathologic activation of C5a receptors, such as rheumatoid arthritis and kidney diseases.
- Patent Landscape: Part of a broader portfolio of C5aR antagonist patents held by ChemoCentryx, Inc.
- Regulatory Aspects: Subject to patent term restoration based on FDA determinations.
- Impact on Industry: Provides a balanced approach to innovation by having narrower and clearer claims.
FAQs
What is the main subject of United States Patent 8,906,938?
The main subject of this patent is C5aR antagonists, specifically substituted piperidine compounds that modulate the C5a receptor.
Who are the inventors and assignee of this patent?
The inventors include Pingchen Fan, Kevin Lloyd Greenman, Manmohan Reddy Leleti, Yandong Li, Jay Powers, Hiroko Tanaka, Ju Yang, and Yibin Zeng. The assignee is ChemoCentryx, Inc.
What is the expiration date of this patent?
The patent is set to expire on December 21, 2029.
What diseases can the compounds described in this patent treat?
The compounds are useful in treating diseases involving the pathologic activation of C5a receptors, such as rheumatoid arthritis and kidney diseases like ANCA-associated vasculitis.
Is there a generic version of Tavneos available?
As of the current date, there is no generic version of Tavneos available in the United States.
Cited Sources:
- United States Patent and Trademark Office. US10660897.pdf.
- Drugs.com. Generic Tavneos Availability.
- Hoover Institution. Patent Claims and Patent Scope.
- Google Patents. US8906938B2 - C5aR antagonists.
- Federal Register. Volume 88 Issue 227.
